This randomized not blinded clinical trial study performs on 100 pregnant patients. Inclusion criteria: Pregnant women with post term pregnancy are candidate for induction of labor, bishop score < 5, and vertex presentation of fetus.
Exclusion criteria: Spontaneous contraction, rupture of membranes and have a uterine scar, bishop score >5, placenta previa and any contraindication of vaginal delivery. The main purpose of this study is comparing Laminaria and Transcervical catheter efficacy for induction of labor.
Patients divide to two groups with 50 person in each of them. For group 1 insert Transcervical catheter and for the other one use Laminaria for ripening of cervix.
30 minute after inserting, induction of labor by oxytocin was started according to classic protocol.
Then, the time lapse from the beginning of induction to enter the active phase of labor and also from the start of induction till delivery and appearing the side effects in both groups will assess.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105016355N1
Registration date:2011-09-07, 1390/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-07, 1390/06/16
Registrant information
Name
Leila Hormozi
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1338 4023
Email address
hormozi.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Transcervical Catheter and Laminaria efficacy on induction of labor in post term pregnancy
Public title
Comparison of Transcervical Catheter and Laminaria efficacy on induction of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with post term pregnancy are candidate for induction of labor; bishop score < 5; vertex presentation of fetus.
Exclusion criteria: Spontaneous contraction; rupture of membranes and have a uterine scar; bishop score >5; Placenta previa; any contraindication of vaginal delivery.
Age
From 15 years old to 44 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapur University of Medical Sciences Ethic committee
Street address
Golestan Bolvar,Ahvaz
City
Ahwaz
Postal code
6193673166
Approval date
2010-06-07, 1389/03/17
Ethics committee reference number
ٍETH-006
Health conditions studied
1
Description of health condition studied
Post term pregnancy
ICD-10 code
048
ICD-10 code description
Prolonged pregnancy
Primary outcomes
1
Description
Induction of labor to delivery interval
Timepoint
Per 2 hours
Method of measurement
Cervical dilatation by vaginal examination (cm)
Secondary outcomes
1
Description
Induction of labor to active phase interval
Timepoint
Per 2 hours
Method of measurement
Cervical dilatation by vaginal examination (cm)
Intervention groups
1
Description
Intervention group 1. Transcervical catheter (Foley) 16F, contains 30 cc saline, between internal os and fetus head, 30 minutes before oxytosin
Category
Treatment - Other
2
Description
Intervention group 2. Laminaria medium size (3-4) in endocervical canal, 30 minutes before oxytosin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Emam Khomeini Hospital
Full name of responsible person
Dr. Leila Hormozi - Obstetrics & Gynecology Resident
Street address
Ahvaz Emam Khomeini Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Bolvar
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Leila Hormozi
Position
Obstetrics & Gynecology Resident
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Bolvar
City
Ahwaz
Postal code
61335
Phone
+98 61 1222 2922
Fax
+98 61 1292 1835
Email
Hormozi841@yahoo.com
Web page address
ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Nazari Forooshani
Position
Assistant Professor Of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Bolvar
City
Ahvaz
Postal code
61335
Phone
+98 61 1373 8302
Fax
+98 61 1333 2036
Email
Ali_nazari25@yahoo.com
Web page address
ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapur University of Medical Sciences
Full name of responsible person
Leila Hormozi
Position
Obstetrics & Gynecology Resident
Other areas of specialty/work
Street address
Ahwaz Jondishapur University of Medical Sciences, Golestan Bolvar
City
Ahvaz
Postal code
61335
Phone
+98 61 1373 8302
Fax
+98 61 1333 2036
Email
Web page address
ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)